RESEARCH TRIANGLE PARK, N.C., March 31, 2011 /PRNewswire/ --GlaxoSmithKline (NYSE: GSK) today published a list of payments made during 2010 for clinical research studies led by U.S. healthcare professionals. Clinical trials are an important step in the lengthy process of discovering and developing new medicines. GSK works with these independent institutions and healthcare professionals because they have considerable expertise in conducting research that contributes to the body of knowledge about diseases and potential new treatments.
"These institutions and associated healthcare professionals contribute their knowledge, time and expertise to partner with the pharmaceutical industry to discover and develop new medicines and vaccines to treat and prevent diseases," said Moncef Slaoui, GSK's Chairman of Research and Development. "We understand the changing expectations for our industry in regards to these partnerships and so we are choosing to take steps to provide increased transparency to details about the way we work together. We continue to believe that working together to examine the benefits and risks of potential medicines is critical if we are to maintain our contribution to improving global health."
The report on payments for research (http://us.gsk.com/html/responsibility/research-investigators.html) lists 127 studies involving 595 different lead researchers or principal investigators (PIs) in the U.S. who were associated with those studies. The list also includes the clinical research study number (which links to details about the research disclosed on http://www.gsk-clinicalstudyregister.com/ and on www.clinicaltrials.gov), the city and state of the lead researcher or PI and the amount of money the institution received during the year for a particular study.
In total, GSK paid $28.5 million to these institutions during 2010 for their help in conducting research on topics including cardiovascular disease, chronic obstructive pulmonary disease (COPD), macular degeneration, renal and other cancers. The payments include the costs for study visits and any other costs to conduct the research such as: procedures (diagnostic tests, laboratory services and patient assessments), detailed monitoring of clinical outcomes and drug safety, and institutional overhead, etc. In most cases, GSK has no knowledge as to the amount of money paid to the individual PI or lead researcher.
This is a small part of the significant investment made by GSK in research and development each year. In 2010, the company invested $6.9 billion for R&D globally. GSK has progressed 10 new compounds and vaccines into Phase III clinical trials since the start of 2010. The company has a peer-leading pipeline of about 30 late-stage assets.
Beginning in January 2009, GSK implemented a series of initiatives in the U.S. to increase transparency about its research to the public, including:
- Posting all observational studies, meta-analyses and studies of terminated compounds on the GSK Clinical Study Register [http://www.gsk-clinicalstudyregister.com/] – GSK began posting a broader range of study results on the GSK Register. GSK already posted on the register the results of all Phase l-lV clinical trials of marketed medicines and the results of certain observational studies and studies of terminated compounds.
- Committing to publish all clinical research results in the scientific literature – GSK publishes all clinical research of its medicines either as manuscripts in peer-reviewed journals or, when studies are not accepted for publishing, provides context and interpretation via the GSK Clinical Study Register to supplement the result summary which is posted.
- Reporting clinical trial principal investigator names and institutions – The names of the principal investigators participating in GSK-sponsored clinical trials, together with the institutions they are working in, are included in the protocol summary for new studies posted to the GSK Clinical Study Register.
- Providing quarterly updates to its report listing grants and sponsorships to U.S.-based health-related organizations. This report includes grants to organizations such as hospitals, teaching institutions, managed care organizations, professional associations, patient advocacy groups, and continuing medical education companies located in the U.S. and Puerto Rico.
GSK also provides an update on payments to U.S. healthcare professionals
GSK also posted an update to its quarterly listing of healthcare professionals who have been paid for speaking on behalf of the company or advising GSK (http://us.gsk.com/html/responsibility/speakers-advisors.html). The update showed that in 2010, there were 5,331 healthcare professionals in the U.S. paid a total of $56.8 million for such activities. The company has voluntarily posted these payments since 2009.
"GSK believes properly engaging doctors to share their knowledge with other physicians in peer-to-peer education programs helps them keep up with advances in medicine," said Deirdre Connelly, President of North America Pharmaceuticals for GSK. "Society expects our business to be conducted openly and transparently and in a way that does not create even a perception of inappropriate influence," she said. "Our industry has made significant changes in how we operate and at GSK we continually re-examine how we conduct our business to ensure that our values are reflected in all our practices."
Other recent changes in the way GSK conducts its U.S. commercial business to be more open and transparent include:
- Strengthened guidelines that cover U.S. healthcare professionals who speak and consult with the company. Since 2010, GSK has done the following:
- Expanded background checks and qualification criteria for potential speakers to exclude anyone with a state or federal sanction or discipline.
- Lowered the limit on payments to healthcare professionals in the U.S. for speaking and advising. Fees are now restricted to a maximum of $100,000 a year for an individual, down from $150,000 in 2009.
- Changed its policy to prohibit speakers from using their own slides in programs they conduct for GSK. This change was made to ensure that all the available information on medicines – both benefits and risks – is presented in a fair and balanced way, and in accordance with the FDA approved product label.
- Strengthened internal controls to distinguish the exchange of scientific information from promotional activities. GSK has expanded internal guidelines that govern the interaction and exchange of information between GSK and external communities to advance scientific and medical understanding, including the appropriate development and use of our medicines and vaccines, the management of disease, and improved patient care. This is clearly distinct from commercial promotion, which educates customers on the prescription, supply, sale or use of medicines and vaccines. These principles ensure a clear, visible distinction between commercial interests and our scientific activities such as advisory boards, publications, scientific congress activities, medical education, and other engagement with key stakeholders.
For example, this policy goes beyond industry standards to defer any disease awareness programs by GSK related to a product in development until after product authorization.
- Implemented a unique continuing medical education (CME) program. On Jan. 1, 2010, GSK implemented a system that limits CME grant applications to approximately 20 academic medical centers and national-level professional medical associations. All CME providers must be directly accredited by a recognized accrediting body, and GSK now funds only CME by not-for-profit providers. The first grants were awarded mid-year to programs designed to close evidence-based gaps in patient healthcare, and to support the optimal performance of healthcare professionals. [www.partnersinknowledge.com]
- Shifting pay incentives in the sales organization from a focus on prescription volumes to providing information and support that healthcare professionals want and need. GSK is putting in place a new and unique incentive compensation system in which individual sales representatives do not receive bonus pay based on the prescriptions they generate but on their scientific and business knowledge, feedback from customers, and overall performance of the business unit they support.
- Stopped television advertising for erectile dysfunction medicines. GSK's goal is to reach the patient where they are, rather than blanket the airwaves with general advertising. GSK makes every effort to avoid advertising in places that are easily accessible to children.
- Introduced a Third Party Code of Conduct for GSK suppliers. This sets out the standards we expect suppliers to meet and covers ethical conduct; labor practices and environmental, health and safety standards; and management. We require new suppliers to sign a statement confirming that they comply with the principles of the Code before they can do business with GSK.
- Stressed values and integrity as part of performance management for all employees. Employees have a values and integrity objective included in their annual performance plans. They are evaluated for not only "what" they do, but also "how" they do it. Compliance officers are embedded in each business unit to implement our training and education programs, and use our systems and processes to ensure we are operating and behaving as we should.
GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information go to us.gsk.com, follow us on twitter.com/GSKUS or visit our blog (www.morethanmedicine.us.gsk.com/blog/).
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2010.
SOURCE GlaxoSmithKline plc